The Recall Desk
ModerateFDA (Drugs)·D-0395-2023·Announced 2023-03-08

Accord Healthcare Recalls Glimepiride Tablets Due to CGMP Deviations

Accord Healthcare is recalling Glimepiride 4 mg tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. Approximately 1.16 million bottles across the United States, Puerto Rico, and Canada are affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II precautionary recall with no reported illnesses or injuries. The CGMP deviations represent a manufacturing process violation, but no specific product defect has been confirmed.

Plain-English summary

Accord Healthcare, Inc. is recalling Glimepiride Tablets USP, 4 mg, due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The affected product was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India and distributed in the United States, Puerto Rico, and Canada.

The recall includes approximately 1,158,839 bottles packaged in 100-count and 500-count containers. Affected batch numbers span multiple production runs with expiration dates ranging from March 31, 2023 through August 31, 2025.

Patients taking the recalled product should not stop their medication without consulting their healthcare provider. Individuals who have this product should contact their pharmacy or healthcare provider for replacement product or guidance.

The recalled product

Product
GLIMEPIRIDE (GLIMEPIRIDE)
Brand
GLIMEPIRIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Antidiabetic
Hazard
Affected units
1,158,839

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Batches: a) P2001868
  • Exp. Date 3/31/2023
  • P2001869 Exp. Date 3/31/2023
  • P2002810 Exp. Date 5/31/2023
  • P2005473 Exp. Date 8/31/2023
  • P2005552 Exp. Date 9/30/2023
  • P2101986 Exp. Date 3/31/2024
  • P2101989 Exp. Date 3/31/2024
  • P2101988 Exp. Date 3/31/2024
  • P2101991 Exp. Date 3/31/2024
  • P2101992 Exp. Date 3/31/2024
  • R2100736 Exp. Date 6/30/2024
  • R2100737 Exp. Date 6/30/2024
  • P2105281 Exp. Date 7/31/2024
  • R2101441 Exp. Date 9/30/2024
  • R2101454 Exp. Date 10/31/2024
  • R2101455 Exp. Date 10/31/2024
  • R2101468 Exp. Date 10/31/2024
  • R2101469 Exp. Date 10/31/2024
  • R2200096 Exp. Date 12/31/2024

UPCs (4)

  • 0316729003018
  • 0316729002011
  • 316729003018
  • 316729003162

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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Same hazard · manufacturing deviation

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